The European Medicines Agency has published for public consultation an ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing applications and registration packages for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell cultures initiated from characterized cell banks of human or animal origin (e.g., mammalian, avian, insect).
Comments should be provided using this template and sent to ich@ema.europa.eu by February 10, 2023.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations.
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
